Can anyone help me with the question of what physical form the above records can take? Let me explain my situation to clarify the question. I would be most interested to hear form people who have been through an FDA audit.
During an audit, does the document register need to be in an electronic format or hardcopy? If in hardcopy; does the register need to be in format where the information is entered manually or it can be softcopy and printed when required?
Our DMR is an electronic document which can be printed upon request. The DHR is a compilation of production and quality records, etc. and it is in hard copy, since the forms are completed by the folks who do the jobs. Our DHFs may be a combination of hard copy records and electronic documents.
I hope this helps.
__________________
Gidget Stough, ASQ CQA
"It's easier to do a job right than to explain why you didn't." - Martin Van Buren
DMR, DHR and DHF physical form
Re: DMR, DHR and DHF physical form
Linear Mode
